Image-guided stereotactic body radiotherapy for primary kidney cancer (STONE)
Official title: Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
Run by Istituto Clinico Humanitas · NCT07299357 · Data updated 2026-11-12
This will try high-dose, focused radiation (SBRT) to treat adults with a single small primary kidney cancer who are not good candidates for surgery or who decline surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 53 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Milan, Milan and 1 other locations) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | December 2027 |
| Study ends | December 2033 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07299357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed single cT1 renal cell carcinoma ≤7 cm, ECOG 0–2, medically inoperable or at high surgical risk or who have declined surgery, without metastases and with eGFR ≥30 mL/min are ideal candidates.
✕Probably not a fit
Patients with metastatic disease, tumor diameter >7 cm, prior radiotherapy to the same site, eGFR <30 mL/min, or life expectancy under three months are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects data from routine clinical practice on patients receiving image-guided stereotactic body radiotherapy (SBRT) delivering ablative doses in a few high-dose fractions to primary renal tumors ≤7 cm. It enrolls adults with histologically confirmed cT1 renal cell carcinoma who are medically inoperable, at high surgical risk, or have declined surgery, and excludes those with metastatic disease, prior radiotherapy to the same site, or very poor kidney function. No study-specific procedures are required beyond standard clinical care and follow-up imaging to monitor tumor response and kidney function. The compiled safety, kidney function, and local control outcomes aim to support broader adoption of SBRT as a noninvasive option for inoperable primary kidney tumors.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive, outpatient option to control or cure small primary kidney tumors while avoiding surgery and preserving kidney function.
How similar studies have gone: SBRT is already used successfully for many tumor types and small observational series for renal cell carcinoma report promising local control, but randomized, definitive evidence for ablative SBRT in primary kidney cancer is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * ECOG performance status 0 - 2 * Histologically confirmed diagnosis of primary RCC * cT1 stage tumor with single lesion with maximum diameter of 7 cm * Medically inoperable or at high risk of complication from surgery, or declined surgery * Absence of metastatic disease * Written informed consent Exclusion Criteria: * Estimated glomerular filtration rate (eGFR) \< 30 mls/min * Previous radiotherapy on the same site * Previous systemic therapy for RCC * Tumor diameter larger than 7 cm * Presence of metastatic disease * Life expectancy \< 3 months
Where it's running
-
Irccs Humanitas Research Hospital
Rozzano, Milan, Italy Recruiting -
Humanitas PIO X
Milan, Milan, Italy Not yet recruiting
Study contacts
- Study coordinator: Ciro Franzese, MD, radiation oncologist
- Email: ciro.franzese@hunimed.eu
- Phone: +39 0282247454
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.